Regional Anesthesia MorbidityNCT06941259
Effects of Combined Rectus Sheath and Ilioinguinal Nerve Block on Opioid Consumption in HALDN
A study testing Rectus sheath and ilioinguinal nerve block with physiological saline and Rectus sheath and ilioinguinal nerve block with local anaesthesia in people with Regional Anesthesia Morbidity, run by Koç University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this double-blind randomized control clinical trial is to investigate the effectiveness of regional anaesthesia blocks (rectus sheath block and ilioinguinal nerve block) on pain management in patients undergoing hand assisted laparoscopic donor nephrectomy surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Regional Anesthesia Morbidity
- What is being tested?
- Rectus sheath and ilioinguinal nerve block with physiological saline and Rectus sheath and ilioinguinal nerve block with local anaesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Mar 2025to 28 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The donors reviewed by the transplant committee and deemed suitable for nephrectomy.
- Laparoscopic hand assisted donor nephrectomy operation is planned.
Who cannot join
- Allergy to any of the drugs to be used in treatment
- Patients using chronic narcotics or narcotic receptor agonists
- Patients with psychiatric disorders
- Patients with chronic organ failure
- Patients without end organ damage
- The patients who did not give consent
- Foreign national patients
- Patients with American Society of Anaesthesiologists (ASA) physical status classification score III and above
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Combined Rectus Sheath and Ilioinguinal Nerve Block on Opioid Consumption in Hand-Assisted Laparoscopic Donor Nephrectomy Patients: A Randomized Controlled Double-Blind Prospective Study
The goal of this double-blind randomized control clinical trial is to investigate the effectiveness of regional anaesthesia blocks (rectus sheath block and ilioinguinal nerve block) on pain management in patients undergoing hand assisted laparoscopic donor nephrectomy surgery. The main question it aims to answer is:
Does combined rectus sheath block and ilioinguinal nerve block lower the amount of postoperative opioid consumption? Does reduced postoperative opioid consumption reduce the incidence of potential opioid related side effects? Does the application of nerve block affect length of hospital stay?
Read more
Researchers will compare patients who had nerve blocks with regional anaesthesia to a placebo group to see if total postoperative opioid consumption.
Participants will be randomly divided in two. Regional anaesthesia with local anaesthesia or a placebo will be performed. Patients will be followed 24 hours postoperatively to measure total opioid consumption.
Possible side effects, complications and length of hospital stay will be noted.
Read the detailed description
In this study, it was planned to provide pain management after HALDN by applying a combined rectus sheath block and ilioinguinal nerve block. It is aimed to demonstrate the postoperative analgesic effectiveness of combined rectus sheath and ilioinguinal nerve block applied in addition to general anaesthesia in HALDN surgery. It was aimed to examine the amount of narcotic analgesic consumption in patients who received local anaesthetic for the first 24 hours after surgery. Regional anaesthesia applications with physiological saline, defined as 'Sham Block' in the literature, were preferred as the comparison group.
This method is a widely used comparison method and is used to obtain a double-blind study design.
- Conditions
- Regional Anesthesia Morbidity
- Being tested
- Rectus sheath and ilioinguinal nerve block with physiological saline, Rectus sheath and ilioinguinal nerve block with local anaesthesia
- Keywords
- rectus sheath block, ilioinguinal nerve block, hand assisted donor nephrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectus sheath and ilioinguinal nerve block with physiological salineProcedure or surgery
Also called Group A (Sham)
Rectus sheath and ilioinguinal nerve block without local anaesthesia
Rectus sheath and ilioinguinal nerve block with local anaesthesiaProcedure or surgery
Also called Group B (Block)
Rectus sheath and ilioinguinal nerve block with local anaesthesia
| Study group | Role | What they receive |
|---|---|---|
| Group Sham | Sham comparator | After the induction of general anaesthesia, the rectus sheath block and ilioinguinal nerve block will be performed to patients with a solution containing only physiological saline. Receives: Procedure: Rectus sheath and ilioinguinal nerve block with physiological saline |
| Group Block | Active comparator | After the induction of general anaesthesia, the rectus sheath block and ilioinguinal nerve block will be performed to patients with a solution containing 0.25% bupivacaine. Receives: Procedure: Rectus sheath and ilioinguinal nerve block with local anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome
Determination of the total amount of narcotic painkillers used during this period.
Measured: 24 hours post-surgery
Secondary outcomes (5)
Secondary Outcome
Numeric rating scale scores for pain after surgery. Numeric rating scale scores for pain of 1 being minimum amount of pain and 10 being the worse pain.
Measured: 24 hours post-surgery
Secondary Outcome
Incidence of narcotic-related side effects
Measured: 24 hours post-surgery
Secondary Outcome
Length of hospital stay
Measured: through patient discharge postoperative, an average of 5 days postoperatively
Secondary Outcome
Determination of the total amount of narcotic painkillers used.
Measured: 1,3,6,12 hours post-surgery
Secondary Outcome
Numeric rating scale scores for pain after surgery. Numeric rating scale scores for pain of 1 being minimum amount of pain and 10 being the worse pain.
Measured: 1,3,6,12 hours post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start30 Mar 2025
- Primary completion28 Jul 2025
- Study completion28 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Regional Anesthesia MorbidityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group A: After patients anesthetized under general anaesthesia, a combined rectus sheath block and ilioinguinal nerve block will be applied with physiological saline. Group B: After patients anesthetized under general anaesthesia, a combined rectus sheath block and ilioinguinal nerve block will be applied with 0.25% bupivacaine.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yasemin Sincer, MD, Principal investigator, Koç University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06941259
- Sponsor's protocol ID
- 2024.394.IRB1.046
- Status last verified
- Jan 2025
- First submitted
- 30 Jan 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ozkalayci O, Karakaya MA, Yenigun Y, Cetin S, Darcin K, Akyollu B, Arpali E, Kocak B, Gurkan Y. Effects of erector spinae plane block on opioid consumption in patients undergoing hand-assisted laparoscopic donor nephrectomy: a randomized controlled trial. Minerva Anestesiol. 2024 Mar;90(3):154-161. doi: 10.23736/S0375-9393.23.17706-6. Epub 2024 Feb 2.
PubMed 38305014Gunaydin B, Ucar T, Arpali E, Akyollu B, Akinci S, Karatas C, Oztorun K, Kocak B. Hand-assisted laparoscopic donor nephrectomy: 1864 cases in 15 years of experience. Turk J Med Sci. 2022 Aug;52(4):1322-1328. doi: 10.55730/1300-0144.5438. Epub 2022 Aug 10.
PubMed 36326419
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Combined Rectus Sheath and Ilioinguinal Nerve Block on Opioid Consumption in Hand-Assisted Laparoscopic Donor Nephrectomy Patients: A Randomized Controlled Double-Blind Prospective Study
- ClinicalTrials.gov ID
- NCT06941259
- Acronym / sponsor ID
- 2024.394.IRB1.046
- Conditions
- Regional Anesthesia Morbidity
- Keywords
- rectus sheath block, ilioinguinal nerve block, hand assisted donor nephrectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Study start
- 30 Mar 2025 (actual)
- Primary completion
- 28 Jul 2025 (actual)
- Study completion
- 28 Jul 2025 (actual)
- First posted
- 23 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this double-blind randomized control clinical trial is to investigate the effectiveness of regional anaesthesia blocks (rectus sheath block and ilioinguinal nerve block) on pain management in patients undergoing hand assisted laparoscopic donor nephrectomy surgery. The main question it aims to answer is:
Does combined rectus sheath block and ilioinguinal nerve block lower the amount of postoperative opioid consumption? Does reduced postoperative opioid consumption reduce the incidence of potential opioid related side effects? Does the application of nerve block affect length of hospital stay?
Researchers will compare patients who had nerve blocks with regional anaesthesia to a placebo group to see if total postoperative opioid consumption.
Participants will be randomly divided in two. Regional anaesthesia with local anaesthesia or a placebo will be performed. Patients will be followed 24 hours postoperatively to measure total opioid consumption.
Possible side effects, complications and length of hospital stay will be noted.
Detailed description
In this study, it was planned to provide pain management after HALDN by applying a combined rectus sheath block and ilioinguinal nerve block. It is aimed to demonstrate the postoperative analgesic effectiveness of combined rectus sheath and ilioinguinal nerve block applied in addition to general anaesthesia in HALDN surgery. It was aimed to examine the amount of narcotic analgesic consumption in patients who received local anaesthetic for the first 24 hours after surgery. Regional anaesthesia applications with physiological saline, defined as 'Sham Block' in the literature, were preferred as the comparison group.
This method is a widely used comparison method and is used to obtain a double-blind study design.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Group A: After patients anesthetized under general anaesthesia, a combined rectus sheath block and ilioinguinal nerve block will be applied with physiological saline. Group B: After patients anesthetized under general anaesthesia, a combined rectus sheath block and ilioinguinal nerve block will be applied with 0.25% bupivacaine.
| Arm | Type | Receives |
|---|---|---|
| Group Sham | Sham comparator | Procedure: Rectus sheath and ilioinguinal nerve block with physiological salineAfter the induction of general anaesthesia, the rectus sheath block and ilioinguinal nerve block will be performed to patients with a solution containing only physiological saline. |
| Group Block | Active comparator | Procedure: Rectus sheath and ilioinguinal nerve block with local anaesthesiaAfter the induction of general anaesthesia, the rectus sheath block and ilioinguinal nerve block will be performed to patients with a solution containing 0.25% bupivacaine. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The donors reviewed by the transplant committee and deemed suitable for nephrectomy.
- Laparoscopic hand assisted donor nephrectomy operation is planned.
Key exclusion criteria (8 listed)
- Allergy to any of the drugs to be used in treatment
- Patients using chronic narcotics or narcotic receptor agonists
- Patients with psychiatric disorders
- Patients with chronic organ failure
- Patients without end organ damage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rectus sheath and ilioinguinal nerve block with physiological salineAlso: Group A (Sham)Rectus sheath and ilioinguinal nerve block without local anaesthesia | Procedure or surgery | Group Sham |
| Rectus sheath and ilioinguinal nerve block with local anaesthesiaAlso: Group B (Block)Rectus sheath and ilioinguinal nerve block with local anaesthesia | Procedure or surgery | Group Block |
Primary outcome
Primary Outcome
Time frame: 24 hours post-surgery
Determination of the total amount of narcotic painkillers used during this period.
5 secondary outcomes
Secondary Outcome
Time frame: 24 hours post-surgery
Secondary Outcome
Time frame: 24 hours post-surgery
Secondary Outcome
Time frame: through patient discharge postoperative, an average of 5 days postoperatively
Secondary Outcome
Time frame: 1,3,6,12 hours post-surgery
Secondary Outcome
Time frame: 1,3,6,12 hours post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Results publication: PubMed 38305014Ozkalayci O, Karakaya MA, Yenigun Y, Cetin S, Darcin K, Akyollu B, Arpali E, Kocak B, Gurkan Y. Effects of erector spinae plane block on opioid consumption in patients undergoing hand-assisted laparoscopic donor nephrectomy: a randomized controlled trial. Minerva Anestesiol. 2024 Mar;90(3):154-161. doi: 10.23736/S0375-9393.23.17706-6. Epub 2024 Feb 2.
- Results publication: PubMed 36326419Gunaydin B, Ucar T, Arpali E, Akyollu B, Akinci S, Karatas C, Oztorun K, Kocak B. Hand-assisted laparoscopic donor nephrectomy: 1864 cases in 15 years of experience. Turk J Med Sci. 2022 Aug;52(4):1322-1328. doi: 10.55730/1300-0144.5438. Epub 2022 Aug 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasemin Sincer, MD principal investigator
Koç University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rectus sheath and ilioinguinal nerve block with physiological saline and Rectus sheath and ilioinguinal nerve block with local anaesthesia in people with Regional Anesthesia Morbidity, run by Koç University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome (time frame: 24 hours post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06941259, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.